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Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens

NCT06479148 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-12-27

No results posted yet for this study

Summary

A Prospective, Single-Center, Randomized Clinical Investigation to evaluate the safety and performance of the enVista® Aspire ™ (EA) intraocular lens (IOL) when compared to the MX60E monofocal IOL (control lens) and an IOL with a slightly extended depth of focus (active comparator lens) for potentially improved optical properties.

Conditions

  • Cataract

Interventions

DEVICE

enVista® Aspire™

Eyes will receive enVista® Aspire™ lenses

DEVICE

An IOL with a slightly extended depth of focus

Eyes will receive lenses with a slightly extended depth of focus

DEVICE

MX60E

Eyes will receive MX60E lenses

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2024-12-12
Completion
2024-12-12
FDA Device
Yes

Countries

  • Honduras

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06479148 on ClinicalTrials.gov